JOHNSON-&-JOHNSON

Johnson & Johnson today announced encouraging first-in-human clinical
data for an investigational HIV-1 vaccine regimen in development at its
Janssen Pharmaceutical Companies.
In an oral presentation of
the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on
HIV Science (IAS 2017), the “mosaic”-based vaccine regimen from Janssen
Vaccines & Prevention B.V. (Janssen) appeared to be well-tolerated and
elicited HIV-1 antibody responses in 100% of healthy volunteers (n=393).

“Finding a preventive vaccine has proven to be one of the biggest
scientific challenges in the 35-year quest to end the HIV pandemic. A
successful preventive vaccine for HIV will need to provide broad
protection against a wide range of viral strains,” said Professor Dan
Barouch, Harvard Medical School, Director of the Center for Virology and
Vaccine Research at Beth Israel Deaconess Medical Center and a key
collaborator for APPROACH. “These promising, early-stage results suggest
that these vaccines utilizing mosaic immunogens should be evaluated
further for their potential ability to achieve this historic goal.”

Significant progress has been made in the global battle against
HIV/AIDS, including the development of critical antiretroviral
treatments and HIV prevention tools, yet the disease remains one of the
greatest global health threats of our time. An estimated 37 million
people are currently living with HIV-1 globally, and nearly 2 million
people become newly infected each year. An effective HIV vaccine is
elusive due to the unique properties of the virus – including its
genetic diversity and ability to mutate rapidly.

Mosaic-based vaccines contain immunogens created using genes from
different HIV subtypes responsible for HIV-1 infections worldwide. These
immunogens are delivered through viral vectors, including Janssen’s AdVac®
technology based on adenovirus serotype 26 (Ad26). The viral vectors are
combined with other components such as soluble proteins to form
mosaic-based prime-boost vaccine regimens that first prime and then
boost the immune system, with the aim of producing stronger and
longer-lasting immunity to HIV.

Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson said,
“In recent years, a new optimism has emerged that we will find an
effective HIV vaccine in our lifetime. The results from today’s study
add to that belief and we look forward to advancing to the next stage of
clinical development as quickly as possible.”

In pre-clinical studies, regimens incorporating mosaic vaccines
demonstrated protection against infection with an HIV-like virus. The
most effective prime-boost regimen in these studies reduced the
per-exposure risk of infection by 94 percent and resulted in 66 percent
complete protection after six exposures.

Based on immunologic responses observed in APPROACH, as well as
protection observed in pre-clinical studies, a lead HIV-1 vaccine
regimen comprising Janssen’s Ad26 mosaic candidate and the Clade C gp140
soluble protein has been selected as the basis for further evaluation in
a potential Phase 2b proof-of-concept efficacy study. Should this study
move forward, Janssen and its global partners anticipate initiating this
investigation in southern African countries in late 2017 or early 2018.

About the APPROACH Study

APPROACH (HIV-V-A004/NCT02315703) is a multi-center, randomized,
parallel-group, placebo-controlled, double-blind Phase 1/2a study in 393
healthy HIV-uninfected adults in the US, Rwanda, Uganda, South Africa
and Thailand. It is evaluating the safety, tolerability and
immunogenicity of various mosaic-based, prime-boost vaccine regimens for
HIV-1. These vaccine regimens contain two prime doses of the mosaic
viral vector Ad26.Mos.HIV and two boosts of either Ad26.Mos.HIV,
MVA-Mosaic and/or different doses of the soluble protein Clade C gp140
adjuvanted with aluminum phosphate. Vaccination schedules have been
completed for all study participants and 12-month follow-up after the
4th dose is underway.

Results presented at IAS 2017 suggest that all vaccine regimens appeared
to be well-tolerated. Injection site pain, headache and fatigue were the
most common reported adverse events. The primary analysis post 3rd
vaccination showed that most active vaccine regimens elicited antibody
responses in 100% of study participants. Antibody titers against
autologous Clade C and heterologous cross-clade Env antigens increased
in groups boosted with gp140 protein, irrespective of vector. After the
4th vaccination, humoral and cellular responses further increased.

The APPROACH study was sponsored by Janssen with support from partner
organizations including Beth Israel Deaconess Medical Center (BIDMC);
the United States Military HIV Research Program (MHRP) at the Walter
Reed Army Institute of Research (WRAIR), with the Henry M. Jackson
Foundation for the Advancement of Military Medicine (HJF); the National
Institute of Allergy and Infectious Diseases (NIAID), part of the US
National Institutes of Health (NIH); the Ragon Institute; the
International AIDS Vaccine Initiative (IAVI); and the HIV Vaccine Trials
Network (HVTN).

About Janssen’s HIV Preventive Vaccine

Janssen’s HIV-1 AdVac®
-based vaccine regimen, along with the
company’s investigational Ebola and inactivated polio vaccine
candidates, utilize Janssen’s PER.C6®
production cell line
technology, which has the potential to reduce costs by increasing
vaccine production at lower reactor volume.

Since 2005, Janssen Vaccines & Prevention B.V. has been participating in
the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) program under grants AI066305, AI078526 and
AI096040. Janssen’s HIV vaccine program has also received funding from
the United States Military HIV Research Program and the Ragon Institute.

Please visit www.jnj.com/HIV
for further details on the breadth of HIV science being presented by
Johnson & Johnson companies and its partners.

About Johnson & Johnson

Caring for the world one person at a time inspires and unites the people
of Johnson & Johnson. We embrace research and science – bringing
innovative ideas, products and services to advance the health and
well-being of people. Our approximately 126,400 employees at more than
230 Johnson & Johnson operating companies work with partners in health
care to touch the lives of over a billion people every day, throughout
the world.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at www.janssen.com
.
Follow us at @JanssenGlobal
.

Cautions Concerning Forward-Looking
Statements

This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995, regarding
development of a potential preventive vaccine for HIV. The reader is
cautioned not to rely on these forward-looking statements. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially from the
expectations and projections of Janssen Vaccines & Prevention B.V.
and/or Johnson & Johnson. Risks and uncertainties include, but are not
limited to: challenges and uncertainties inherent in product research
and development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in behavior
and spending patterns of purchasers of health care products and
services; changes to applicable laws and regulations, including global
health care reforms; and trends toward health care cost containment. A
further list and descriptions of these risks, uncertainties and other
factors can be found in Johnson & Johnson's Annual Report on Form 10-K
for the fiscal year ended January 1, 2017, including under “Item 1A.
Risk Factors,” its most recently filed Quarterly Report on Form 10-Q,
including under the caption “Cautionary Note Regarding Forward-Looking
Statements,” and the company's subsequent filings with the Securities
and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or
on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.